(86 days)
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No
The summary describes a dental alloy and its intended use in manufacturing, with no mention of AI or ML technology.
No.
The device is described as a gold-based alloy used for dental restorations (porcelain to metal fabrication), which is a material used in the manufacturing of prosthetics, not a device for therapy.
No
Explanation: The device description states that MIRACLE 98 is an alloy intended for manufacturing porcelain to metal fabrication of single units. Its function is to provide strength, durability, and color to dental restorations, not to diagnose medical conditions.
No
The device description clearly states it is a "Gold based alloy" and a "high gold ceramic alloy," indicating it is a physical material used in dental fabrication, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "manufacturing: - Porcelain to metal fabrication of single units". This describes a material used in the creation of dental restorations, which are implanted or placed in the body.
- Device Description: The description details a "High Noble, Micro-fine, Yellow, Gold based alloy" used for dental restorations. This is a material used in the fabrication process, not a diagnostic test performed on a sample from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a material used in the manufacturing of a medical device (a dental restoration).
N/A
Intended Use / Indications for Use
MIRACLE 98 is intended for manufacturing: - Porcelain to metal fabrication of single units
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
SIRICE the composition of the legally marketed alloy and the new device is very similar, it may be assumed that the biological compatibility of the alloys is also very similar. MIRACLE 98 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single unit with lower fusing porcelains and indirect restorative composites. MIRACLE 98 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of physical and mechanical properties:
Alloy: Jel Bios Pure / Miracle 98
Melting Point Range (degree F): 1,900-2,010 / 1,904-2,015
Hardness (Vickers): 50 / 45
Yield Strength (psi): 55,000 / 54,000
Elongation (%): 45.0 / 50.0
CTE (x10-6/degree C): 15.3 / 15.1
Density (g/cm3): 19.2 / 19.2
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
K03/010
JUN 2 5 2003 510(K) SUMMARY
Submitter of 510(k):
SB LUCIUS, INC.
9778 Katella Ave. Ave. Ste 205, Anaheim, CA 92804 Phone: (714) 530-2814, Fax : (714) 530-3448,
| Contact person: | Dae Kyu Chang |
|---|---|
| Phone: | (714) 530-2814 |
| Fax: | (714) 530-3448 |
| E-mail: | Gatorkr@yahoo.co.kr |
| Date of Summary: | March. 26, 2003 |
| Trade name: | MIRACLE 98 |
| Common: | Dental casting alloy |
| Classification name: | Gold based alloys and precious metal alloys for clinical use |
| Product code: | EJT |
| Classification: | Class II |
Legally marketed device: Heraeous Kulzer's Jel Bios Pure 510(k) number: K002645
SJMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Tixst methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
COMPOSITION (WEIGHT)
| Device Name | Au (%) | Pt (%) | In (%) | Zn (%) |
|---|---|---|---|---|
| Jel Bios Pure | 99.30 |